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To evaluate whether a generic drug approved under an ANDA meets all the criteria in section 1860D-14B(g)(1)(C)(ii) of the Act, we proposed at 428.101(a)(3) to codify the policy established in section 30 of the revised Medicare Part D Drug Inflation Rebate Guidance whereby CMS would use ( specified FDA resources such as the Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) [684] and NDC Directory [685] to determine whether a generic drug meets the definition of a Part D rebatable drug